A Study of Volociximab in Combination With Gemcitabine in Metastatic Pancreatic Cancer

Completed · Phase 2

Conditions studied: Pancreatic Cancer

In brief

This clinical trial is being conducted to determine tumor response and preliminary safety of a monoclonal antibody that specifically binds to a cell surface receptor (α5β1 integrin) that is required for the establishment of new blood vessels during tumor growth, a process known as angiogenesis.

Key facts

Study ID

NCT00401570

Run by

AbbVie (prior sponsor, Abbott)

People needed

40

Starts

2005-03-01

Expected to finish

2008-06-01

Last updated by the study team

2013-01-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, 18 years of age or older.
• Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas.
• May have received prior immunotherapy (including monoclonal antibodies) or vaccine therapies.
• Measurable disease, according to RECIST criteria.
• Negative pregnancy test (women of childbearing potential only).
• Pretreatment laboratory levels that meet specific criteria.

You may not qualify if…

• Prior treatment with Volociximab (M200) or inhibitors of α5β1 integrin (antibodies or small molecules) or gemcitabine and other chemotherapeutic regimens.
• Known hypersensitivity to murine proteins or chimeric antibodies or other components of the product.
• Use of any investigational drug within 4 weeks prior to screening or 5 half-lives of the prior investigational drug (whichever is longer).
• Monoclonal antibody therapy within 4 weeks of the first dose of Volociximab.
• Central Nervous System (CNS) tumor or metastasis.
• History of bleeding disorders within the past year.
• Medical conditions that may be exacerbated by bleeding.

Where it is running

• Site Reference ID/Investigator# 70538 — Pittsburgh, Pennsylvania, United States
• Site Reference ID/Investigator# 70537 — Nashville, Tennessee, United States
• Site Reference ID/Investigator# 70534 — Glasgow, United Kingdom
• Site Reference ID/Investigator# 70533 — Leeds, United Kingdom
• Site Reference ID/Investigator# 70536 — Manchester, United Kingdom
• Site Reference ID/Investigator# 70535 — Northwood, United Kingdom

Full record on ClinicalTrials.gov

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